U.S. patent application number 13/184614 was filed with the patent office on 2011-11-03 for system and method for airway manipulation.
This patent application is currently assigned to KONINKLIJKE PHILIPS ELECTRONICS N.V.. Invention is credited to Michael T. DINEEN, Andrew FRAZIER, Chad C. ROUE, Erik J. VAN DER BURG.
Application Number | 20110270031 13/184614 |
Document ID | / |
Family ID | 36124330 |
Filed Date | 2011-11-03 |
United States Patent
Application |
20110270031 |
Kind Code |
A1 |
FRAZIER; Andrew ; et
al. |
November 3, 2011 |
SYSTEM AND METHOD FOR AIRWAY MANIPULATION
Abstract
Methods and devices are disclosed for manipulating the airway,
such as to treat obstructive sleep apnea. An implant is positioned
within the body with respect to the airway. The spatial orientation
of the airway is manipulated, directly or indirectly, to affect the
configuration of the airway. In general, the implant is manipulated
to displace the trachea in an inferior direction, resist superior
displacement of the trachea and/or to alter the tracheal wall
tension. The implant restrains the trachea in the manipulated
configuration.
Inventors: |
FRAZIER; Andrew; (SUNNYVALE,
CA) ; ROUE; Chad C.; (SAN JOSE, CA) ; DINEEN;
Michael T.; (PORTOLA VALLEY, CA) ; VAN DER BURG; Erik
J.; (LOS GATOS, CA) |
Assignee: |
KONINKLIJKE PHILIPS ELECTRONICS
N.V.
EINDHOVEN
NL
|
Family ID: |
36124330 |
Appl. No.: |
13/184614 |
Filed: |
July 18, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10958205 |
Oct 4, 2004 |
7997266 |
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13184614 |
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Current U.S.
Class: |
600/37 |
Current CPC
Class: |
A61F 2002/046 20130101;
A61B 2017/0458 20130101; A61B 17/3421 20130101; A61B 2017/0454
20130101; A61F 2/82 20130101; A61B 17/0487 20130101; A61F 2/04
20130101; A61B 2017/0496 20130101; A61B 2017/0453 20130101; A61B
17/3423 20130101; A61B 2017/06176 20130101; A61F 2002/065 20130101;
A61B 2017/0464 20130101; A61B 17/0401 20130101; A61F 2250/0004
20130101 |
Class at
Publication: |
600/37 |
International
Class: |
A61F 2/02 20060101
A61F002/02 |
Claims
1-13. (canceled)
14. A method of treating a patient comprising the steps of:
implanting a device across a first branch of the airway between a
first segment of the airway and a second segment of the airway;
changing the relative angle between the first segment and the
second segment; and manipulating the device to restrain the
relative angle between the first segment and the second
segment.
15. The method of treating a patient of claim 14, wherein the
changing step comprises increasing the relative angle between the
first segment and the second segment.
16. The method of treating a patient of claim 14, wherein the
changing step comprises decreasing the relative angle between the
first segment and the second segment.
17. (canceled)
18. An endotracheal remodeling device, comprising: a main body
portion for positioning within the trachea; a first branch portion
for positioning within a first bronchial tube; and a second branch
portion for positioning within a second bronchial tube; wherein the
angle between the first and second bronchial tube portions is
adjustable throughout a range from a first angle to a second angle,
and configured to retain the second angle.
19. The device of claim 18, wherein the angle between the first
bronchial tube and trachea is adjustable separately from the angle
between the second bronchial tube and the trachea.
20. The device of claim 19, wherein the angle between the second
bronchial tube and the trachea is adjustable separately from the
angle between the first bronchial tube and the trachea.
21. The device of claim 19, wherein the angle between the second
bronchial tube and the trachea is fixed.
22. An airway remodeling device, comprising: a first segment for
positioning within a first portion of the airway; and a second
segment for positioning within a second portion of the airway;
wherein the angle between the first portion of the airway and
second portion of the airway is adjustable throughout a range from
a first angle to a second angle, and configured to retain the
second angle.
23. The device of claim 22, further comprising a third segment for
positioning within a third portion of the airway, wherein the angle
between the third portion of the airway and an adjacent portion of
the airway is adjustable through a range from a third angle to a
fourth angle, and configured to retain the fourth angle.
24. The device of claim 23, wherein the adjacent portion of the
airway is the first portion of the airway.
25. The device of claim 23, wherein the first segment, second
segment and third segment generally have a Y-configuration.
26. The device of claim 23, wherein the first segment, second
segment and third segment generally have a serial configuration.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] This invention relates generally to a system and method for
treating upper airway obstruction, sleep disordered breathing,
upper airway resistance syndrome and snoring by manipulating the
trachea and/or esophagus.
[0003] 2. Description of the Related Art
[0004] Respiratory disorders during sleep are recognized as a
common disorder with significant clinical consequences. During the
various stages of sleep, the human body exhibits different patterns
of brain and muscle activity. In particular, the REM sleep stage is
associated with reduced or irregular ventilatory responses to
chemical and mechanical stimuli and a significant degree of muscle
inhibition. This muscle inhibition may lead to relaxation of
certain muscle groups, including but not limited to muscles that
maintain the patency of the upper airways, and create a risk of
airway obstruction during sleep. Because muscle relaxation narrows
the lumen of the airway, greater inspiratory effort may be required
to overcome airway resistance. This increased inspiratory effort
paradoxically increases the degree of airway resistance and
obstruction through a Bernoulli effect on the flaccid pharyngeal
walls during REM sleep.
[0005] Obstructive Sleep Apnea (OSA) is a sleep disorder that
affects up to 2 to 4% of the population in the United States. OSA
is characterized by an intermittent cessation of airflow in the
presence of continued inspiratory effort. When these obstructive
episodes occur, an affected person will transiently arouse, regain
muscle tone and reopen the airway. Because these arousal episodes
typically occur 10 to 60 times per night, sleep fragmentation
occurs which produces excessive daytime sleepiness. Some patients
with OSA experience over 100 transient arousal episodes per
hour.
[0006] In addition to sleep disruption, OSA may also lead to
cardiovascular and pulmonary disease. Apnea episodes of 60 seconds
or more have been shown to decrease the partial pressure of oxygen
in the lung alveoli by as much as 35 to 50 mm Hg. Some studies
suggest that increased catecholamine release in the body due to the
low oxygen saturation causes increases in systemic arterial blood
pressure, which in turn causes left ventricular hypertrophy and
eventually left heart failure. OSA is also associated with
pulmonary hypertension, which can result in right heart
failure.
[0007] Radiographic studies have shown that the site of obstruction
in OSA is isolated generally to the supralaryngeal airway, but the
particular site of obstruction varies with each person and multiple
sites may be involved. A small percentage of patients with OSA have
obstructions in the nasopharynx caused by deviated septums or
enlarged turbinates. These obstructions may be treated with
septoplasty or turbinate reduction procedures, respectively. More
commonly, the oropharynx and the hypopharynx are implicated as
sites of obstruction in OSA. Some studies have reported that the
occlusion begins with the tongue falling back in an
anterior-posterior direction (A-P) to contact with the soft palate
and posterior pharyngeal wall, followed by further occlusion of the
lower pharyngeal airway in the hypopharynx. This etiology is
consistent with the physical findings associated with OSA,
including a large base of tongue, a large soft palate, shallow
palatal arch and a narrow mandibular arch. Other studies, however,
have suggested that increased compliance of the lateral walls of
the pharynx contributes to airway collapse. In the hypopharynx,
radiographic studies have reported that hypopharyngeal collapse is
frequently caused by lateral narrowing of the pharyngeal airway,
rather than narrowing in the A-P direction.
[0008] OSA is generally diagnosed by performing overnight
polysomnography in a sleep laboratory. Polysomnography typically
includes electroencephalography to measure the stages of sleep, an
electro-oculogram to measure rapid eye movements, monitoring of
respiratory effort through intercostal electromyography or
piezoelectric belts, electrocardiograms to monitor for arrhythmias,
measurement of nasal and/or oral airflow and pulse oximetry to
measure to measure oxygen saturation of the blood.
[0009] Following the diagnosis of OSA, some patients are prescribed
weight loss programs as part of their treatment plan, because of
the association between obesity and OSA. Weight loss may reduce the
frequency of apnea in some patients, but weight loss and other
behavioral changes are difficult to achieve and maintain.
Therefore, other modalities have also been used in the treatment of
OSA, including pharmaceuticals, non-invasive devices and
surgery.
[0010] Among the pharmaceutical treatments, respiratory stimulants
and drugs that reduce REM sleep have been tried in OSA.
Progesterone, theophylline and acetozolamide have been used as
respiratory stimulants, but each drug is associated with
significant side effects and their efficacy in OSA is not well
studied. Protriptyline, a tricyclic antidepressant that reduces the
amount of REM sleep, has been shown to decrease the frequency of
apnea episodes in severe OSA, but is associated with
anti-cholinergic side effects such as impotence, dry mouth, urinary
retention and constipation.
[0011] Other modalities are directed at maintaining airway patency
during sleep. Oral appliances aimed at changing the position of the
soft palate, jaw or tongue are available, but patient discomfort
and low compliance have limited their use. Continuous Positive
Airway Pressure (CPAP) devices are often used as first-line
treatments for OSA. These devices use a sealed mask which produce
airflow at pressures of 5 to 15 cm of water and act to maintain
positive air pressure within the pharyngeal airway and thereby
maintain airway patency. Although CPAP is effective in treating
OSA, patient compliance with these devices is low for several
reasons. Sleeping with a sealed nasal mask is uncomfortable for
patients. Smaller sealed nasal masks may be more comfortable to
patients but are ineffective in patients who sleep with their
mouths open, as the air pressure will enter the nasopharynx and
then exit the oropharynx. CPAP also causes dry nasal passages and
congestion.
[0012] Surgical treatments for OSA avoid issues with patient
compliance and are useful for patients who fail conservative
treatment. One surgery used for OSA is uvulopalatopharyngoplasty
(UPPP). UPPP attempts to improve airway patency in the oropharynx
by eliminating the structures that contact the tongue during sleep.
This surgery involves removal of the uvula and a portion of the
soft palate, along with the tonsils and portions of the tonsillar
pillars. Although snoring is reduced in a majority of patients who
undergo UPPP, the percentage of patients who experience reduced
frequency of apnea episodes or improved oxygen saturation is
substantially lower. Postoperatively, many patients that have
undergone UPPP continue to exhibit oropharyngeal obstruction or
concomitant hypopharyngeal obstruction. Nonresponders often have
physical findings of a large base of tongue, an omega-shaped
epiglottis and redundant aryepiglottic folds. UPPP is not a
treatment directed at these structures. UPPP also exposes patients
to the risks of general anesthesia and postoperative swelling of
the airway that will require a tracheostomy. Excessive tissue
removal may also cause regurgitation of food and liquids into the
nasopharynx.
[0013] Laser-assisted uvulopalatopharyngoplasty (LAUP) is a similar
procedure to UPPP that uses a CO2 laser to remove the uvula and
portions of the soft palate, but the tonsils and the lateral
pharyngeal walls are not removed.
[0014] For patients who fail UPPP or LAUP, other surgical
treatments are available but these surgeries entail significantly
higher risks of morbidity and mortality. In genioglossal
advancement with hyoid myotomy (GAHM), an antero-inferior portion
of the mandible, which includes the attachment point of the tongue
musculature, is repositioned forward and in theory will pull the
tongue forward and increase airway diameter. The muscles attached
to the inferior hyoid bone are severed to allow the hyoid bone to
move superiorly and anteriorly. Repositioning of the hyoid bone
expands the retrolingual airspace by advancing the epiglottis and
tongue base anteriorly. The hyoid bone is held in its new position
by attaching to the mandible using fascia. Variants of this
procedure attach the hyoid bone inferiorly to the thyroid
cartilage.
[0015] A laser midline glossectomy (LMG) has also been tried in
some patients who have failed UPPP and who exhibit hypopharyngeal
collapse on radiographic studies. In this surgery, a laser is used
to resect the midline portion of the base of the tongue. This
involves significant morbidity and has shown only limited
effectiveness.
[0016] In some patients with craniofacial abnormalities that
include a receding mandible, mandibular or maxillomandibular
advancement surgeries may be indicated for treatment of OSA. These
patients are predisposed to OSA because the posterior mandible
position produces posterior tongue displacement that causes airway
obstruction. In a mandibular advancement procedure, the mandible is
cut bilaterally posterior to the last molar and advanced forward
approximately 10 to 14 mm. Bone grafts are used to bridge the bone
gap and the newly positioned mandible is wire fixated to the
maxilla until healing occurs. Mandibular advancement may be
combined with a Le Fort I maxillary osteotomy procedure to correct
associated dental or facial abnormalities. These procedures have a
high morbidity and are indicated only in refractory cases of
OSA.
[0017] Experimental procedures described in the clinical literature
for OSA include the volumetric radiofrequency tissue ablation and
hyoidplasty, where the hyoid bone is cut into several segments and
attached to a brace that widens the angle of the U-shaped hyoid
bone. The latter procedure has been used in dogs to increase the
pharyngeal airway lumen at the level of the hyoid bone. The canine
hyoid bone, however, is unlike a human hyoid bone because the
canine hyoid bone comprises nine separate and jointed bones, while
the human hyoid bone comprises five bones that are typically fused
together.
[0018] Notwithstanding the foregoing, there remains a need for
improved methods and devices for treating obstructive sleep
apnea.
SUMMARY OF THE INVENTION
[0019] There is provided in accordance with one aspect of the
present invention, a method of treating apnea. The method comprises
the steps of securing a device with respect to a trachea, the
trachea having a superior direction and an inferior direction. The
device is manipulated to advance at least a portion of the trachea
in the inferior direction. The securing step may comprise securing
the device to the trachea. The securing step may also comprise
securing the device to tissue adjacent the trachea, such as the
hypopharynx, esophagus and/or bronchi. The device may initially be
positioned within the trachea, or adjacent the trachea. The
manipulating step may comprise placing the device under tension to
pull or push at least a portion of the trachea in an inferior
direction. The manipulating step may comprise radially expanding
the device within the trachea. The manipulating step may
alternatively comprise adjusting the device to change the angle
between first and second bronchial tubes.
[0020] In accordance with another aspect of the present invention,
there is provided a method of treating a patient. The method
comprises the steps of providing a tracheal device having a first
end with a first attachment structure, and a second end with a
second attachment structure. The first attachment structure is
attached to a first point on or within the trachea, and the second
attachment structure is attached to a second point on or within the
trachea. The distance between the first and second attachment
points is thereafter shortened.
[0021] In accordance with a further aspect of the present
invention, there is provided a tracheoesophageal implant. The
implant comprises an elongate body, adapted for positioning on or
within the esophagus. A first attachment structure is provided on
the body, and a second attachment structure is provided on the
body, spaced apart from the first attachment structure. The implant
is configured for positioning on or within the esophagus and for
attaching to the esophageal wall. The implant is further adapted to
manipulate the spacing between the first attachment structure and
second attachment to indirectly affect the portion of the trachea
around and between the first and second attachment points.
[0022] In accordance with a further aspect of the present
invention, there is provided a tracheal implant. The implant
comprises an elongate body, adapted for positioning on or within
the trachea. A first attachment structure is provided on the body,
and a second attachment structure is provided on the body, spaced
apart from the first attachment structure. The implant is
configured for positioning on or within the trachea and for
attaching to the tracheal wall. The implant is further adapted to
manipulate the spacing between the first attachment structure and
second attachment structure to affect the portion of the trachea
about the region between the first and second attachment points.
The implant is adaptable for placement in the esophagus or tissue
adjacent to the trachea, thereby affecting the trachea indirectly.
Adjacent tissue to the trachea includes but is not limited to the
esophagus, clavicles, ribs, bronchi and carina.
[0023] In accordance with another aspect of the present invention,
there is provided a method of treating a patient. The method
comprises the steps of providing an airway manipulation device
having a first end with a first attachment structure, and a second
end with a second attachment structure. The first attachment
structure is attached to a first point on or within the airway, and
the second attachment structure is attached to a second point on or
within the airway. The distance between the first and second
attachment points is thereafter altered.
[0024] In accordance with a further aspect of the present
invention, there is provided a tracheal remodeling device. The
remodeling device comprises a main body portion, for positioning on
or within the trachea. A first branch portion is provided, for
positioning on or within a first bronchial tube. A second branch
portion is provided, for positioning on or within a second
bronchial tube. The angle between the first and second bronchial
tube portions is adjustable throughout a range from a first angle,
which approximates the normal anatomical relationship, to a second
angle, which places inferior direction tension on the trachea. The
remodeling device is configured to retain the second angle. The
angle between the first bronchial tube and trachea may also be
adjustable separately from the angle between the second bronchial
tube and the trachea. The angle between the second bronchial tube
and trachea may also be adjustable separately from the angle
between the first bronchial tube and the trachea. The angle between
the second bronchial tube and the trachea may also be fixed.
[0025] In one embodiment of the invention, an airway remodeling
device is provided. The device comprises a first segment for
positioning within a first portion of the airway, and a second
segment for positioning within a second portion of the airway,
wherein the angle between the first portion of the airway and
second portion of the airway is adjustable throughout a range from
a first angle to a second angle, and configured to retain the
second angle. The device may also comprise a third segment for
positioning within a third portion of the airway, wherein the angle
between the third portion of the airway and the adjacent portion of
the airway is adjustable through a range from a third angle to a
fourth angle, and configured to retain the fourth angle. The
adjacent portion of the airway may be the first portion or second
portion of the airway. The first segment, second segment and third
segment may generally have a Y-configuration or a serial
configuration.
[0026] Further features and advantages of the present invention
will become apparent to those of skill in the art in view of the
disclosure herein, when considered together with the attached
drawings and claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] The structure and method of using the invention will be
better understood with the following detailed description of
embodiments of the invention, along with the accompanying
illustrations, in which:
[0028] FIG. 1 is a sagittal view of the pharynx.
[0029] FIGS. 2A and 2B depict the hyoid bone with respect to the
thyroid and cricoid cartilage in a lateral and anterior view,
respectively. FIG. 2C is a superior view of the hyoid bone.
[0030] FIG. 3 illustrates the musculature attached to the hyoid
bone in a lateral view.
[0031] FIG. 4 shows an anterior view of the musculature attached to
the hyoid bone. The anatomical right portion of the body depicts
the deep musculature and the anatomical left portion of the body
shows the superficial musculature.
[0032] FIG. 5 shows an anterior view of the trachea relative to the
laryngeal structures and the bronchial tree.
[0033] FIGS. 6A and 6B show one embodiment of the invention
comprising a radially expandable endotracheal stent for
manipulating the trachea.
[0034] FIGS. 7A and 7B show one embodiment of the invention
comprising a longitudinal member with a helical spring structure
capable of axially or longitudinally compressing a portion of the
trachea.
[0035] FIGS. 8A and 8B show one embodiment of the invention adapted
to attach endolumenally and comprises a slotted tongue with a screw
mechanism for altering the distance between the proximal and distal
ends of the implant.
[0036] FIGS. 9A through 9C represent one embodiment of the
invention comprising a fixed length implant for manipulating the
trachea.
[0037] FIGS. 10A and 10B illustrate one embodiment of the invention
comprising a bifurcated tubular configuration.
[0038] FIGS. 11A and 11B depict one embodiment of the invention
comprising endoscopically placed sutures with a cinching member for
securing the suture.
[0039] FIGS. 12A and 12B show one embodiment of the invention
comprising tracheal shortening implants placed on the exterior
surface of the trachea.
[0040] FIG. 13 depicts one embodiment of an esophageal implant in a
schematic sagittal view through the hypopharynx, trachea and
esophagus.
[0041] FIGS. 14A and 14B show one embodiment of the invention
wherein the trachea is tensioned inferiorly by attachment to an
anatomical structure such as the clavicles.
[0042] FIGS. 15A and 15B illustrate embodiments of the invention
wherein the trachea is tensioned inferiorly by pushing against an
anatomical structure such as the clavicles.
[0043] FIGS. 16A and 16B show one embodiment of the invention for
altering the angle between the left and right mainstem bronchi.
[0044] FIGS. 17A and 17B show another embodiment of the invention
for altering the angle between the left and right mainstem
bronchi.
[0045] FIGS. 18A and 18B depict another embodiment of the invention
for altering the angle between the left and right mainstem
bronchi.
[0046] FIGS. 19A and 19B represent one embodiment of the invention
for altering the angle of one mainstem bronchi.
[0047] FIG. 20A is a side elevational view of a two-segment airway
remodeling stent. FIG. 20B is cross sectional view of the stent
from FIG. 20A.
[0048] FIGS. 21A through 21C depict one embodiment of a
three-segment airway remodeling stent. FIG. 21B is a cross
sectional view of the remodeling stent of FIG. 21A.
[0049] FIG. 21C is a schematic elevational view of the stent of
FIG. 21A following fixation of the stent.
[0050] FIG. 22A depicts another embodiment of a three-segment
airway remodeling stent in a first configuration. FIG. 22B depicts
the remodeling stent of FIG. 22A following fixation.
[0051] FIGS. 23A and 23B are cross sectional views of the fixation
of one embodiment of a unilateral remodeling stent FIGS. 24A and
24B are cross sectional views of the deployment of one embodiment
of a unilateral remodeling stent.
[0052] FIGS. 25A and 25B are cross sectional views of the airway
during deployment of a branched remodeling stent.
[0053] FIGS. 26A and 26B illustrate one embodiment of the invention
for altering the angles of the mainstem bronchi.
[0054] FIGS. 27A and 27B depict embodiments of the invention for
pulling the trachea inferiorly toward the carina.
[0055] FIG. 28 depicts an embodiment of the invention for
displacing the bilateral lungs inferiorly to manipulate the
trachea.
[0056] FIGS. 29A and 29B depict an embodiment of the invention for
bronchoscopically accessing the trachea.
[0057] FIGS. 30A through 30C illustrate one embodiment for
surgically accessing the trachea.
[0058] FIG. 31 shows another embodiment for surgically accessing
the trachea in the thoracic cavity.
[0059] FIG. 32 shows a video-assisted thorascopic surgery (VATS)
approach for accessing the trachea in the thoracic cavity.
[0060] FIGS. 33A through 33C illustrate a minimally invasive
approach for inserting a tracheal manipulation implant into the
pleural apices of the thoracic cavity.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0061] The present invention provides methods and devices for
manipulating the airway. It is hypothesized that the laxity in
pharyngeal structures contributes to the pathophysiology of
obstructive sleep apnea, snoring, upper airway resistance and sleep
disordered breathing. This laxity may be intrinsic to the
pharyngeal structures and/or may be affected by interrelationships
between pharyngeal structures and other body structures. For
example, in the upright position, gravity lessens the effect of
abdominal cavity organs on the diaphragm. When in the prone or
supine position, however, the contents of the abdominal cavity have
a greater tendency to displace the diaphragm superiorly, which in
turn displaces the lungs, bronchi and trachea and other portions of
the airway superiorly and accentuates the laxity of the pharyngeal
structures by reducing the tissue tension normally applied by the
airway on the laryngeal structures. The embodiments of the
invention, however, are not restricted or limited to these
mechanisms or hypotheses.
[0062] In some embodiments of the invention, airway manipulation is
performed by displacing at least a portion of the airway inferiorly
relative to other body structures. In some embodiments of the
invention, airway manipulation may also comprise increasing the
wall tension of the airway without necessarily displacing the
airway. In some embodiments, airway manipulation comprises
resisting superior displacement of the airway that occurs either
continuously or intermittently with sleep related disorders or
other respiratory problems. In some embodiments, airway
manipulation comprises applying a force with an inferior
directional component to at least a portion of the airway. Airway
manipulation can be performed directly on the airway, or indirectly
through tissues or structures adjacent to the airway.
[0063] FIG. 1 is a sagittal view of the structures that comprise
the pharyngeal airway and may be involved in obstructive sleep
apnea. The pharynx is divided, from superior to inferior, into the
nasopharynx 1, the oropharynx 2 and the hypopharynx 3. The
nasopharynx 1 is a less common source of obstruction in OSA. The
nasopharynx is the portion of the pharynx above the soft palate 4.
In the nasopharynx, a deviated nasal septum 5 or enlarged nasal
turbinates 6 may occasionally contribute to upper airway resistance
or blockage. Only rarely, a nasal mass, such as a polyp, cyst or
tumor may be a source of obstruction.
[0064] The oropharynx 2 comprises structures from the soft palate 4
to the upper border of the epiglottis 7 and includes the hard
palate 8, tongue 9, tonsils 10, palatoglossal arch 11, the
posterior pharyngeal wall 12 and the mandible 13. An obstruction in
the oropharynx 2 may result when the tongue 9 is displaced
posteriorly during sleep as a consequence of reduced muscle
activity during REM sleep. The displaced tongue 9 may push the soft
palate 4 posteriorly and may seal off the nasopharynx 1 from the
oropharynx 2. The tongue 9 may also contact the posterior
pharyngeal wall 12, which causes further airway obstruction.
[0065] The hypopharynx 3 comprises the region from the upper border
of the epiglottis 7 to the inferior border of the cricoid cartilage
14. The hypopharynx 3 further comprises the hyoid bone 15, a
U-shaped, free floating bone that does not articulate with any
other bone. The hyoid bone 15 is attached to surrounding structures
by various muscles and connective tissues. The hyoid bone 15 lies
inferior to the tongue 9 and superior to the thyroid cartilage 16.
A thyrohyoid membrane 17 and a thyrohyoid muscle 18 attaches to the
inferior border of the hyoid 15 and the superior border of the
thyroid cartilage 16. The epiglottis 7 is infero-posterior to the
hyoid bone 15 and attaches to the hyoid bone by a median
hyoepiglottic ligament 19. The hyoid bone attaches anteriorly to
the infero-posterior aspect of the mandible 13 by the geniohyoid
muscle 20.
[0066] The position of the hyoid bone relative to the thyroid and
cricoid cartilage is shown in FIGS. 2A and 2B. The hyoid bone is a
U-shaped bone comprising a body 21, two lesser horns 22 and two
greater horns 23, as a shown in a superior view in FIG. 2C. As
shown in FIG. 3, at the pharyngeal level of the hyoid bone, the
hyoid bone forms an anterior portion of the pharynx while a pair of
middle pharyngeal constrictor muscles 24 forms the remaining
portions of the airway. The muscle fibers of the middle constrictor
muscles 24 originate from the greater 23 and lesser horns 22 of the
hyoid bone 15 and fan out posteriorly, inferiorly and superiorly to
the posterior midline pharynx (not shown). A stylohyoid ligament 25
attaches from the cranium to the hyoid bone. FIG. 4 illustrates the
attachments of the extrinsic muscles of the larynx. The left side
of the illustration in FIG. 4 depicts the anatomy of the
superficial musculature and the right side depicts the deeper
musculature. The posterior belly 26 of the digastric muscle
originates from the mastoid process 27 and attaches to the lesser
horn 22 of the hyoid bone 15 as a tendon and then attaches as an
anterior belly 28 to the mandible 13. The stylohyoid muscle 29
originates from the styloid process (not shown) of the cranium and
then splits into two portions upon inserting adjacent to the lesser
horn of the hyoid bone 15 to allow the digastric muscle to pass
anteriorly. Deep to the digastric 26, 28 and stylohyoid 29 muscles
are the hyoglossus muscles 30, attaching to the superior surfaces
of the greater horns 23 of the hyoid bone 15 and inserting into the
lateral areas of the tongue 9. Further deep is the mylohyoid muscle
31, a sheet of muscle that courses between the hyoid bone 15 and
the lateral interior sides of the mandible 13, forming a portion of
the musculature of the floor of the mouth along with the geniohyoid
muscle 20. These muscles move the hyoid bone 15 and tongue 9
superiorly and anteriorly, and are involved in the act of
swallowing. Overlying most of the antero-lateral neck is the
platysma muscle (not shown) that originates over the upper anterior
chest and inserts over the anterior surfaces of the mandible
13.
[0067] The omohyoid muscles are the most lateral of the muscles
that attach to the inferior surface of the hyoid bone 15. The
omohyoid muscles have two bellies 33, 34. The inferior belly 33
attaches to the scapula and the superior belly 34 attaches to the
inferior body of the hyoid bone. The two bellies 33, 34 are joined
by a tendon 32 that is continuous with fascia along the medial ends
of the clavicles 46. Also attached to the inferior surfaces of the
hyoid bone 15 are the sternohyoid muscles 35 that originate at the
manubrium 36 of the sternum and the thyrohyoid 18 muscles that
originate along antero-inferior border of the thyroid cartilage 16.
The inferior muscles of the hyoid bone act to increase the luminal
opening of the pharynx at the level of the hyoid.
[0068] FIG. 5 depicts a trachea relative to the laryngeal
structures and the bronchial tree. The trachea 50 courses from a
subcutaneous position in the neck to a position against the
esophagus and prevertebral fascia at the level of the carina 51.
The carina 51 bifurcates into the left and right mainstem bronchi
52, 53 at the level of the fifth thoracic vertebral body and can be
localized approximately at the same level as the sternal notch. The
average length of the adult trachea is about 11 cm from the
inferior border of the cricoid cartilage to the carina 51. The
trachea 51 may range from about 9 cm to about 15 cm. The trachea 51
has an average internal diameter of about 2.3 cm laterally and
about 1.8 cm anteroposteriorly. The left mainstem bronchus 52 has
an average length of about 4.5 cm and leaves the trachea at about a
135 degree angle. The right mainstem bronchus 53 measures on
average about 2.5 cm in length, is located slightly superior
compared to the left mainstem bronchus 52 and branches from the
carina 51 at about a 155 degree angle.
[0069] There are typically about 18 to about 22 horseshoe-shaped
cartilaginous rings 54 in the human trachea, with approximately two
rings per centimeter. Each ring is about 4 mm in height and is
separated from adjacent rings by about 2 mm of connective tissue.
The horseshoe-shaped rings give the posterior wall of the trachea
50 a slightly flattened appearance. This posterior wall is also
known as the membranous trachea. The airway in an adult is roughly
elliptical. The only complete cartilaginous ring in the normal
airway is the cricoid cartilage 14 of the larynx.
[0070] Calcification of the cricoid cartilage 14 is not unusual,
and calcification of other cartilaginous rings occurs with age. The
trachea 50 is not rigidly fixed to the surrounding tissue and
provides relatively free vertical movement in relation to other
anatomic structures. The most rigid point of fixation below the
cricoid cartilage 14 lies where the aortic arch forms a sling over
the left mainstem bronchus 52. By transecting the suprahyoid
musculature, the inferior mobility of the trachea 50 may be further
increased.
[0071] In the region of the neck, the anterior surface of the
trachea 51 is covered from a superior to inferior direction, by the
isthmus of the thyroid gland, the inferior thyroid veins, the
sternothyroid and sternohyoid muscles, the cervical fascia and by
the branches of the anterior jugular veins. Laterally, the trachea
is adjacent to the common carotid arteries, the right and left
lobes of the thyroid gland, the inferior thyroid arteries and the
recurrent laryngeal nerves.
[0072] In the thoracic cavity, the trachea is covered anteriorly by
the manubrium and sternum, the remains of the thymus gland, the
inominate vein, the aortic arch, the inominate and left common
carotid arteries and the deep cardiac plexus. Posteriorly, the
trachea is in contact with the esophagus, which lies in contact
with the membranous trachea, typically just to the left from the
midline of the trachea. The esophagus is a hollow muscular tube
approximately 18 cm to 26 cm in length that begins superiorly where
the inferior constrictor muscle merges with the cricopharyngeus
muscle to form the upper esophageal sphincter. The esophagus
maintains a radially collapsed configuration except during
swallowing, where the esophageal lumen is capable of expanding up
to 2 cm in the AP direction and 3 cm laterally. To the right of the
trachea are the right pleural membrane and the right vagus nerve.
To the left is the left recurrent laryngeal nerve, the aortic arch,
the left common carotid and subclavian arteries. The recurrent
laryngeal nerves course along the tracheoesophageal groove on both
the right and left sides. The blood supply to the trachea enters
the trachea laterally and originates segmentally from the inferior
thyroid, internal thoracic, supreme intercostals and the bronchial
arteries.
[0073] One embodiment of the invention thus provides methods and
devices for either reducing the axial length of the trachea,
resisting superior direction movement of the trachea, or imparting
inferior direction traction on at least a portion of the trachea.
In an embodiment adapted for shortening the effective length of the
trachea, shortening may occur within the range of from about 5% to
about 30%, and, in certain embodiments, between about 10% and 25%
of the overall length of the trachea. Shortening can occur by
collapsing the connective tissue membranes between adjacent
tracheal rings, thereby reducing the spacing between the tracheal
rings and reducing the tracheal length. The exact degree of
tracheal shortening or inferior direction tracheal traction can be
optimized for a given patient, taking into account the desired
clinical results.
[0074] The foregoing may be accomplished by positioning an implant
within the trachea, positioning an implant adjacent but outside of
the trachea, or both. In an embodiment extending outside of the
trachea, the device may be attached to adjacent tissue structure
such as adjacent musculature or bone such as the clavicle bone. An
implant placed on or within the esophagus can also be used to
indirectly affect the trachea.
[0075] Tracheal shortening may also be accomplished by removing or
effectively removing tissue from the tracheal wall, followed by an
anastomosis of healthy margins of tracheal tissue, which may be
adjacent an area of treated tissue. Shortening of the trachea can
be accomplished by the shrinking or removal of a segment of the
trachea. Tissue removal can be accomplished using any of a variety
of endotracheal cutting devices, followed by anastomosis using
conventional techniques. Tissue shrinkage and/or removal can be
accomplished using any of a variety of energy sources, such as
thermal ablation (laser, RF ablation, microwave, ultrasound and the
like), cryotherapy, or other techniques known in the art.
[0076] In one embodiment of the invention, a device for remodeling
the trachea is provided. FIGS. 6A and 6B show a device comprising
an endoscopically deliverable endotracheal stent 60 having a first
reduced diameter d' and a second expanded diameter d''. In its
first reduced diameter d', the stent 60 is capable of mounting in
or on a catheter, laryngoscope or bronchoscope 62 for passage
through the oropharynx and larynx to the trachea 50. In its second
expanded diameter d'', the stent 60 is capable of enlarging the
diameter of the trachea 50. By taking advantage of Poisson's Ratio,
which is the ratio of transverse strain to longitudinal strain of a
structure, enlargement of the tracheal diameter may be used to
alter the longitudinal characteristics of the trachea 51. In one
embodiment, the stent in the second expanded diameter d'' causes
shortening of the tracheal length, as shown in FIG. 6B. This will
cause an inferior displacement of the portion of the trachea 50
superior to the implantation site of the stent 60. By inferiorly
moving a portion of the trachea, remodeling of the laryngeal
structures superior to the trachea occurs and can alleviate at
least a portion of the airway obstruction that occurs in
obstructive sleep apnea. In one embodiment, placement of the stent
60 causes increased longitudinal tension in the trachea 50 to
remodel the laryngeal structures.
[0077] The stent 60 may be expandable in response to an extrinsic
force for expansion, such as a balloon. Balloon expandable stent
configurations may have a lattice, slotted, helical or any of a
variety of configurations as is known in the art. Alternatively,
the stent 60 may be a self expandable structure which is restrained
in a first, small cross sectional configuration d' for endotracheal
navigation, and enlargeable upon removal of a restraint to assume a
second, enlarged cross sectional configuration d''. Self expandable
stents can be constructed to have any of a variety of expansion
ratios and radial strength, as is well understood in the
cardiovascular arts. For example, endotracheal stents may be
constructed from a zig zag wire wall pattern in which the stent
comprises a plurality of adjacent segments. Each segment includes a
plurality of proximal apexes and a corresponding plurality of
distal apexes, connected by walls struts.
[0078] The stent may further comprise an anti-migration component
for resisting movement of the stent during implantation or with
long-term use. The anti-migration component may comprise at least
one hook, barb, spike, suture, adhesive or tissue ingrowth surface
to further engage the tracheal wall.
[0079] In another embodiment of the invention, a device for
manipulating the trachea is provided. The device comprises a
longitudinal member with at least one proximal end and at least one
distal end, wherein the proximal ends and distal ends of the member
are adapted to engage a body structure with respect to the trachea.
The device may be adapted for endolumenal placement. Endolumenal
placement includes but is not limited to the trachea, the airway
and/or the esophagus. In one embodiment, at least one end of the
longitudinal member is adapted for engaging a portion of the inner
tracheal or bronchial wall. The proximal and distal ends may be
configured with at least one hook, spike, barb, clip or other
configuration known in the art to facilitate engagement of the body
structure. In some embodiments, the attachment surface of the body
structure may be prepared with drilling, roughening or other
treatment to facilitate attachment of the device. The proximal and
distal ends may be further configured to engage the respiratory
tract between the tracheal or bronchial rings and utilize the
integrity of the rings to further secure the device. The proximal
ends and distal ends need not have the same configuration.
[0080] In one embodiment, the longitudinal member is capable of at
least moving the proximal and distal ends closer together along the
longitudinal axis of the member. The member may be configured to
have internal bias for moving the proximal and distal ends towards
each other. The longitudinal member may be capable of elastic
deformation in at least the longitudinal direction. In another
embodiment, the internal bias may be manually adjustable. The
member may be configured to allow manual adjustment of the distance
between the ends, without an independent biasing force. In one
embodiment, the longitudinal member is capable of moving the
proximal and distal ends both closer and farther apart.
[0081] In one embodiment, the longitudinal member comprises an
elongate member wherein the proximal and distal ends of the body
are each capable of engaging at least one point of the respiratory
tract. Multiple devices may be used to achieve the desired tracheal
manipulation. In one embodiment of the invention, shown in FIGS. 7A
and 7B, the elongate member comprises a helical spring structure 70
having an internal bias capable of moving the two ends closer
together. The diameter D of the helical spring structure 70 may
range from about 1 mm to about 30 mm. In another embodiment, the
diameter ranges from about 3 mm to about 20 mm. In some embodiments
of the invention, the device may be capable of both longitudinal
shortening between the ends and radial expansion as shown in FIGS.
6A and 6B. In another embodiment, depicted in FIGS. 8A and 8B, the
elongate member comprises a slotted structure 80 with adjustable
screw 82 capable of altering the distance between the two ends 84,
86 with the application of a rotational force to the screw 82.
[0082] In FIGS. 9A through 9C, one embodiment comprises an elongate
member 90 with a fixed length. At least one end 92 of the member 90
is first engaged to a body structure so that force can be applied
to the member 90 to manipulate the trachea 50. In one embodiment,
the distal end 92 of the elongate member 90 is attached to an
inferior portion of the trachea 50. A superior force is then
applied to the partially attached elongate member 90 to cause
longitudinal compression of the trachea 50 superior to the
insertion site. The remaining end 94 is then engaged to a superior
portion of the trachea 50 to secure the tracheal manipulation. The
elongate member 90 is then released from the delivery device
96.
[0083] In one embodiment, the invention comprises a tubular member
with a lumen to provide airflow through the tubular member. In one
embodiment the tubular member comprises a series of connected
rings. The proximal and distal ends of the tubular member are
adapted to engage the inner surface of the respiratory tract along
at least one diameter. In a further embodiment of the invention,
shown in FIGS. 10A and 10B, the tubular member 100 comprises one
proximal end 102 and two distal ends 104, 106 wherein the two
distal ends 104, 106 are adapted to engage left and right mainstem
bronchi 52, 53. The distal ends 104, 106 are connected to the
proximal end 102 of the tubular member 100 by movable members 108
that are capable of forming an interference fit or a mechanical
interfit with the rings of the tubular member such that the movable
members 108, when pulled into the tubular member 100, are capable
of resisting separation from the rings of the longitudinal member.
In one embodiment, the movable member 108 comprises slidable tubing
with corrugations capable of forming an interference fit. In one
embodiment, the movable member comprises a suture or wire that can
be drawn tight and fixed.
[0084] In still another embodiment of the invention, the device
comprises at least one tracheal suture where the proximal end of
the suture is engaged to a superior portion of the trachea and the
distal end of the suture is engaged to an inferior portion of the
respiratory tract at about the carina or mainstem bronchi. In one
embodiment, illustrated in FIGS. 11A and 11B, the suture 110 is
cinched by a cinching member 112 to bring the two suture ends 114,
116 closer together, thereby shortening the trachea 50. In another
embodiment, the suture 110 is cinched using endoscopic knot pushers
known in the art. The suture 110 is then secured to resist
separation of the suture ends 114, 116. In another embodiment, at
least one distal 114 end of the suture is placed within the
inferior portion of the trachea or mainstem bronchi. Force is
applied superiorly to the attached suture to longitudinally shorten
the trachea and the proximal end of the suture is secured to a
superior portion of the respiratory tract. In one embodiment, the
suture or sutures are placed manually by the surgeon in an open
surgical procedure. In another embodiment, the suture or sutures
are placed endoscopically.
[0085] One skilled in the art will understand that the devices
previously described may also be configured for placement on the
external surface of the trachea. In one embodiment, the proximal
and distal ends of at least one elongate member are engaged to the
external tracheal wall to cause shortening of the trachea. FIGS.
12A and 12B depict one example of an external tracheal device
comprising at least one helical spring 120. A tracheal manipulation
device placed on the external surface of the trachea may be placed
through a surgical site at the anterior neck, or through a
thoracotomy or thoracostomy site into the chest cavity. Such
approaches are further described below.
[0086] One skilled in the art will understand that the devices
previously described may also be configured for attachment to
structures adjacent to the trachea, including but not limited to
the esophagus and gastro-esophageal junction. In one embodiment,
the connective tissue between the respiratory tract and the
gastrointestinal tract may be utilized to indirectly affect the
trachea. By reconfiguring tissue adjacent to the trachea, the
connective tissue attached to the trachea can develop tension and
favorably displace or tighten the trachea. In one embodiment of the
invention, an airway manipulation device is placed in the
esophageal lumen. By taking advantage of the attachment between the
trachea and esophagus through the membranous trachea and/or other
fascial tissue, the airway may be manipulated indirectly. In some
embodiments of the invention, indirect airway manipulation is
preferred, to reduce the risk of airway stenosis. In a further
embodiment of the invention, airway manipulation is performed with
devices that affect the lateral and/or posterior walls of the
esophagus. In some embodiments of the invention, avoiding
attachment to the anterior wall of the esophagus may reduce the
risk of forming a tracheoesophageal fistula. FIG. 13 depicts one
embodiment of the invention involving indirect tracheal
manipulation using an esophageal implant 122. The superior end 124
of the implant 122 is engaged to the wall of the esophagus 126
while the inferior end of the implant 122 is anchored to an
inferior structure such as the inferior esophagus or
gastroesophageal junction. Tension created between the superior and
inferior ends of the esophageal implant 122 provides an inferior
directed force to a portion of the esophagus 126, which in turn
will also indirectly apply an inferior directed force to the
trachea 50. Indirect manipulation of the trachea 50 or airway may
be advantageous to reduce aspiration risk from the implant 120 and
during device implantation. Indirect tracheal manipulation may also
reduce the risk of tracheal necrosis and/or tracheal stenosis. An
esophageal implant may also increase tension to the posterior
pharyngeal wall, thereby treating sleep apnea through an additional
mechanism independent of tracheal manipulation, although the
invention is not bound by the mechanisms described.
[0087] In another embodiment of the invention, at least one end of
the longitudinal member is attached to a portion of the airway
while another end is attached to a non-airway structure, such as a
clavicle, manubrium, sternum or rib. A longitudinal member that is
partially attached to a non-tracheal structure may be advantageous
for providing a more stable structure for exerting greater force on
the trachea, or for applying force in particular directions not
achievable by attaching a longitudinal member solely to the trachea
or respiratory tract.
[0088] FIGS. 14A and 14B show one embodiment of the invention
utilizing attachment to a non-tracheal or non-airway structure. The
invention comprises two arcuate bodies 130, 132 for engaging the
tracheal wall between the two arcuate bodies 130, 132. An inner
arcuate body 132 is placed endotracheally while an outer arcuate
body 130 is adapted for placement on the external surface of the
trachea 50. The two arcuate bodies 130 132 having a C-shape
configuration where the proximal ends 134, 136 of the bodies 130,
132 are wider than the distal ends 138, 140 of the bodies 130, 132,
such that the arcuate bodies 130, 132 are capable of wedging the
trachea between them when the inner arcuate body is inserted to
about the same level of the trachea as the outer arcuate body. In
other embodiments, at least one barb or hook on at least one
arcuate body is capable of engaging the tracheal wall. In another
embodiment, at least one barb or hook is capable of piercing the
tracheal wall and engaging the other arcuate body to manipulate the
trachea. The outer arcuate body 130 is further adapted for
attachment of a suture 142, which can be used to anchor the trachea
wedged between the two arcuate bodies 130, 132 to another body
structure such as the clavicles 46, manubrium or sternum for
displacing the trachea inferiorly. FIG. 14A depicts the outer
arcuate body attached to the trachea, while FIG. 14B is a
cross-sectional schematic view of the relationship between the
outer arcuate body and the inner arcuate body with respect to the
trachea. In another embodiment, only an outer arcuate ring is
provided. In this embodiment, the outer arcuate ring is capable of
engaging the external tracheal wall without requiring an
endotracheally placed inner arcuate ring.
[0089] In an alternate embodiment of the invention, the device
comprises a longitudinal member having a body, proximal end and
distal end, wherein the body is capable of generating a separating
force between the proximal end and distal end. FIG. 15A illustrates
the proximal ends 144 of a longitudinal member 145 attached to a
clavicle 143 and the distal end 146 is attached to an inferior
portion of the trachea 50. A separating force is generated and the
distance between the proximal ends 144 and distal end 146 is
increased, thereby pushing the trachea 50 inferiorly. The
separating force may be generated from a fixed length longitudinal
member by distracting the trachea inferiorly prior to attaching the
distal end of the longitudinal member. Optionally, the separating
force may be generated from a dynamic, adjustable source such as an
air piston 147. A dynamic source will allows some relative movement
between the proximal and distal ends of the longitudinal member
145. Relative movement may provide greater comfort to the patient
and decrease any impact of tracheal tension on swallowing compared
to a fixed length implant. In still another embodiment shown in
FIG. 15B, the proximal end 148 of the longitudinal member 149
comprises a cross bar adapted to engage both the right and left
clavicles 143.
[0090] FIGS. 16A and 16B illustrate another embodiment of the
invention for manipulating the airway. In one embodiment, the
Y-shaped support 150 comprises a bifurcated stent with primary 152,
first arm 154 and second arm 156 segments that contain lumens 158
that provide airflow through the support 150. The primary segment
152 is adapted for positioning about or within the carina 51 and/or
airway and the first and second arm segments 154, 156 are adapted
for positioning about or within the right and left mainstem
bronchi, 53, 52 respectively. The support may further comprise a
lining or sleeve 160 made from ePTFE or any of a variety of
biocompatible linings capable of attachment to the support 150.
Attachment of the lining 160 may be performed with adhesives, heat
bonding, suturing or any of a variety of attachment methods known
in the art.
[0091] The implant 150 is adjustable from a first orientation in
which the first and second arm segments 154, 156 are separated by a
first angle S, and a second configuration in which the first and
second arm segments 154, 156 are separated by a second, wider angle
S'. The device is configured to retain the second angle S'. By
widening the angle S between the first and second arm segments 154,
156, the lung tissue surrounding those portions are displaced in a
superior-lateral direction. This allows the bronchial tree to
displace inferiorly, thereby putting inferior direction traction on
the trachea 50. The angular change between the first and second
positions will be a function of the desired clinical result for a
given patient. In general, however, the second angle will be at
least about 5 degrees or 10 degrees, and often at least about 20
degrees or 30 degrees greater than the first angle. By widening the
angle formed between the mainstem bronchi 52, 53, the trachea 50
may be displaced inferiorly with respect to the lungs and thoracic
cavity, thereby manipulating tracheal positioning or tracheal wall
characteristics.
[0092] In one embodiment, the support 150 comprises a plastically
deformable support 150 inserted bronchoscopically to the carina 51
and deformed with operator-applied deformation force using any of a
variety of bronchoscopically manipulable tools known in the art.
Such a support may comprise stainless steel, titanium and others
known in the art. In one embodiment, the support comprises a shape
memory material such as Nitinol that is inserted into the body in a
first contracted configuration and assumes a second original
configuration upon exposure to body heat that alters the
relationship between the right and left mainstem bronchi. In
another embodiment, the primary segment 152 and arm segments 154,
156 are attached by a joint or other articulation for facilitating
change between the first configuration and second configuration.
The joint may be a hinge joint, socket joint or any other joint
capable of movement. In one embodiment, the support may further
comprise a configuration lock for securing the arm segments in the
first and/or second configurations. In one embodiment, the
configuration lock comprises at least one suture for fixing the
spatial relationship between the arm segments. In another
embodiment, the configuration lock comprises a rotatable screw
mechanism.
[0093] The carinal implant 150 may also be enlargeable from a
first, reduced cross section to facilitate endotracheal navigation,
and a second, enlarged cross section for positioning within the
bifurcation. The support 150 is capable of passing through the
oropharynx and larynx to the carina 51 of the trachea 50 by using a
catheter, bronchoscope or other delivery system.
[0094] In another embodiment, shown in FIGS. 17A and 17B, the
support 170 comprises a bar or wire frame 172 that lacks a lumen.
The distal end 174 of the primary segment 180 and distal ends 176,
178 of the arms segments 182, 184 may have an increased surface
area to reduce the risk of broncho-tracheal tissue necrosis
resulting from the exertion of force. The distal ends 174, 176, 178
may have a curved or angled contact surface with the airway to
reduce focal airway pressure that may cause necrosis. Changes to
the relative position between the primary segment 180 and the arm
segments 182, 184 may occur through deformation of the prosthesis,
or facilitated by joints 186 located between the segments 180, 182,
184. Joints 186 may also be provided between the arm segments 182,
184 and their distal ends 176, 178, respectively. In one
embodiment, a rotatable mechanical assembly 171 allows adjustment
and fixation the arm segments 182, 184 positions with respect to
the primary segment 180. Knotted sutures between the segments 180,
182, 184, or other fixation devices known in the art may also be
used to fix the device configuration. The rotatable mechanical
assembly 171 may have an anchor system for maintaining the position
of the support and to prevent distal displacement of the support
170 into the bronchial tree. The anchor system may comprise a
stent, inflatable cuff or one or more wall attachments.
[0095] In another embodiment of the invention, the angles between
each mainstem bronchi 52, 53 and the trachea 50 are separately
adjustable. This embodiment allows one adjustable angle of the
device to be adjustable independent of the other angle relative to
the primary segment. FIGS. 18A and 18B depicts a support 170 where
the first arm segment 184 and second arm segment 182 are
configurable to different positions with respect to the primary
segment 180 through separate rotatable mechanical interfaces 173,
175. In another embodiment, shown in FIGS. 19A and 19B, only one
angle between the first arm segment 184 and the primary segment 180
is adjustable while the other angle between the second arm segment
182 and the primary segment 180 is fixed. In one embodiment, the
length of the second arm segment 182 may be significantly longer
than the first arm segment and have a greater angle with respect to
the primary segment 180 to reduce to overall insertion profile of
the support 170 into the airway.
[0096] FIGS. 20A and 20B depict another embodiment of the invention
comprising a two-segment tubular airway stent 177. The stent is
adapted for insertion into the airway of a patient generally about
the carina 51 and is capable of reorienting the relative positions
of the airway about the stent 177. The stent 177 comprises a first
tubular segment 179 and a second tubular segment 181 connected by a
movable joint 183 and a fixation assembly 185 for securing the
relative position between the first tubular segment 179 and second
tubular segment 181. This embodiment of the invention lacks a
primary segment adapted for positioning within the trachea but
provides an opening 187 in the device to provide the passage of air
between the opening 187 and the ends 189 of the device. As shown in
the cross sectional view in FIG. 20B, each tubular segment 179, 181
may be configured with a zig-zag structure, lattice structure, or
any of a variety of stent-like configurations. The stent may be
self-expandable upon release from its delivery tool, or the device
may require application of external force, such as a balloon
catheter, to expand. The configuration of each tubular segment 179,
181 need not be the same. One skilled in the art can dimension the
device 177 based upon the particular anatomy of a patient. The
joint 183 may be a hinge joint as shown in FIG. 20B, or a
ball-and-socket joint, or any interface between the two segments
179, 181 that allow the device 177 to remodel the surrounding
airway. The stent segments 179, 181 need not be distinct in
structure with respect to each other, thus the joint 183 or joints
may include but are not limited to one or more deformable struts or
links between the two segments 179, 181 that are similar in
structure to the other portions of the stent 177. The fixation
assembly 185 may comprise any of a variety of fixation structures
capable of securing the relative position of the two segments. The
fixation assembly may comprise a suture attaching the two segments,
as shown in FIG. 20B, or a set screw or lynch-pin type of fixation
component.
[0097] In another embodiment, shown in FIGS. 21A through 21C, the
airway remodeling stent 177 further comprises one or more branch
segments 191 adapted to insert into more distal branches of the
airway. The branch segments 191 allow remodeling of the airway into
the distal portions of the lungs and may be beneficial in
redistributing the remodeling force through a greater portion of
the bronchial tubes or lungs. Each segment need not be discreet
from the other segment(s). In some embodiments, a multi-segmented
stent may have a continuous, curved and/or tapering structure,
where a "segment" refers generally to each portion of the stent
separated by a branching point in the airway where the stent is
configured for implantation. FIG. 21A depicts an airway remodeling
stent 171 with a first mainstem segment 179, a second mainstem
segment 181 and a first order branch segment 191 attached to the
second mainstem segment 181. A variety of fixation assemblies may
also be used for this embodiment of the remodeling device, but one
preferred fixation assembly comprises a slidable wire 193 or suture
along the length of a longitudinal curvature of the segments 181,
191 that, when tightened, causes the segments 179, 181, 191 to
assume a different alignment. By altering the design of the
fixation assembly, different reorientation effects may result.
Between any two segments of a stent, creating tension in the
slidable wire 193 may straighten the alignment between the two
segments or increase the angle between two segments. A
straightening alignment is shown in FIGS. 21A to 21C between one
segment 181 and another segment 191. In a multi-segmented or
branching stent, a combination of straightening and increased
curvature or angulation may occur. One skilled in the art will
understand that a remodeling stent may be designed to reorient to
any desired configuration. This particular fixation assembly allows
reorientation of the distal segment 191 of the device while not
requiring access to the most distal segments of the bronchial tree.
Any of a variety of mechanical or friction fits known in the art
may be used.
[0098] Other embodiments of the invention may be configured for
implantation in other portions of the airway. For instance, FIGS.
22A and 22B depict an embodiment comprising a multi-segmented stent
214 configured for implantation along as portion of the trachea,
the left mainstem bronchi 52 and a branch of the mainstem bronchi
216. In this embodiment, the stent is designed with a fixation
assembly 218 along the lesser curvature of stent 214 comprising a
slidable tension wire 220 and one or more conduits 222 for
restricting the sliding path for the tension wire 220. After
implantation into the airway as illustrated in FIG. 22A, tension is
applied to the slidable tension wire 220, causing an increase in
the curvature of the stent 214. This increased curvature
facilitates the displacement of the lung tissue in a
lateral-superior direction and may further enhance concomitant
inferior displacement of the trachea 54.
[0099] In still another embodiment of the invention, illustrated in
FIG. 23A, the bronchoscopic stent comprises a unilateral stent 195
adapted for insertion into one side of the bronchial tree. The
unilateral stent 195 may cross one or more bronchial branches areas
197, 199 within the bronchial tree and may comprise one or more
contiguous or distinct segments. FIG. 23A depicts a three segment
stent, comprising a proximal 201, middle 203 and distal segment
205. The unilateral stent 195 may be placed along any portion of
the bronchial tree and need not include a segment residing in
either mainstem bronchi 52, 53 but will typically include a
mainstem bronchi segment for ease of access, manipulation and/or
retrieval. One skilled in the art can select the dimensions of
different portions of the stent 195 based upon the desired position
within the bronchial tree. The multi-segmented stent 195 has an
alignment system for altering and fixating the relationship between
the segments of the stent. This alignment system 207 may include
one or more hinges 209, a pull wire 211 along the length of the
stent that is attached or anchored generally at a distal portion of
the stent 195, and a restrictor 213 for fixing the wire position.
By placing tension on the pull wire 211, the portions of the stent
195 are brought closer together and into a different alignment,
which in turn can be fixed by a wire restrictor 213 that resist
relief of the wire tension. The wire restrictor 213 may comprise a
conduit that resists movement of a knot in the wire 211 through the
conduit, or a one-way cinching member attached to the wire 211.
Other alignment systems may also be used, including insertion of a
stiffening structure, elastic deformation of the stent 195 back to
its natural alignment or other system capable of altering the
alignment of the stent segments. The alignment system need not
affect the alignment of every segment of the device, as some
segments may be used not for remodeling the bronchial tree but to
resist collapse of the bronchial lumen in portions of the lung
adjacent to remodeled portions. Referring to FIG. 23B, by altering
the relative alignment of a portion of the bronchial tree, the lung
material is displaced in an superior-lateral direction and allows
the lungs to assume a more inferior position, thereby increasing
the tension of the airway.
[0100] In one embodiment of the invention, the device is deformed
from its inherent shape during the insertion of the device and
reverts and realigns upon release from the delivery tool. FIG. 24A
depicts a deformable remodeling stent 215 in its radially collapsed
configuration within a delivery tool 217. The stent 215 comprises a
metallic lattice structure with or without a jacket covering 219
and is capable of elastic deformation from its radially collapsed
state and capable of exerting sufficient force upon expansion to
remodel the surrounding bronchi and pulmonary tissue. Lumens 158 at
the proximal end 221 and distal end 223 allow airflow through the
length of the stent 215. Side openings 187 are provided in the side
wall of the stent 215 to allow airflow to and from bronchial
branches adjacent to the stent 215. Other stent configurations are
known in the art and may be used in addition to a lattice
structure. The stent 215 may have radio-opaque markers visible on
radiography or fluoroscopy, or indicia visible during bronchoscopy
to facilitate positioning of the stent 215 with respect to the
adjacent branches. FIG. 24B depicts the stent deployed in the left
mainstem bronchi having repositioned the pulmonary tissue to allow
inferior displacement of the trachea.
[0101] The remodeling stent may have a branching or serial
configuration. A serial configuration is depicted in FIGS. 24A and
24B. In a serial configuration, the portions of the stent are
generally arranged in an end-to-end fashion. Referring to FIG. 25B,
one embodiment of the invention comprises a remodeling stent 225
with a branching configuration, where the stent 225 has at least
one joint area 227, 229 where three or more portions (331, 333, 335
and 335, 337, 339) of the stent 225 generally attach. The three
portions need not converge at exactly the same point, but only in
the same general area sufficient to position the segments at a
portion of the bronchial tree and the branches of that portion. As
mentioned previously, a branching configuration may enhance the
remodeling effect on lung structure, and/or may be beneficial in
preserving patency of adjacent bronchial lumen with remodeling,
compared to a serially configured remodeling stent. In one
embodiment of the invention, a method for implanting a branched
remodeling stent is provided. Referring to FIG. 25A, the method
comprises inserting a bronchoscopy delivery tool 441 into the
airway of a patient and passing one or more guidewires 443, 445,
447 into one or more branches of the bronchial tree where the stent
225 is to be inserted. Typically, a guidewire will be used for each
distal branch where the branched remodeling stent is to be placed,
but for some embodiments of the invention, the number of guidewires
may be less. The remodeling stent is released from the delivery
tool into the airway where is can self-expand or be expanded to
cause remodeling of the pulmonary structures.
[0102] In another embodiment of the invention, illustrated in FIGS.
26A and 26B, widening the angle between the mainstem bronchi 52, 53
is performed by attaching an airway manipulation device 190 to the
external surface of the trachea 50. In one embodiment of the
invention, the airway manipulation device comprises at least three
C-shaped clamps 192, 194, 196 adapted to engage the external
surfaces of the trachea 50 and mainstem bronchi 51, 52. In one
embodiment, each clamp has an aperture 198 for engaging a suture
200 such that when the sutures placed between the mainstem bronchi
and the tracheal clamps 194, 196 are tightened, the mainstem
bronchi 52, 53 are reoriented superiorly to cause the trachea 50 to
displace inferiorly. FIG. 27A shows an embodiment that may also
synergistically displace at least a portion of the trachea 50
generally about the C-shaped tracheal clamp 192 in an inferior
direction, further enhancing tracheal manipulation. In another
embodiment, shown in FIG. 27B, the invention comprises a proximal
C-shaped clamp 210 without any distal C-shaped clamps. The suture,
ribbon or cord 212 attached to the proximal clamp 210 may be
wrapped around the carina 51 and tightened and reattached to the
same clamp 192. This embodiment of the invention does not
significantly alter the angle between the left 52 and right
mainstem bronchi 53, but compresses the portion of the trachea 50
between the clamp 192 and the carina 51 to manipulate the portion
of the trachea 50 superior to the clamp 192.
[0103] One skilled in the art will understand that any of a variety
of clamps may be used to engage the respiratory tract, including
but not limited to clamps that completely encircle the trachea or
bronchi, malleable split rings or elastic split rings. In one
embodiment, C-shaped rings are preferred to reduce the risk of
necrosis that exists when a full circumference is dissected around
a portion of the respiratory tract. Full circumference dissection
has been known to disrupt the blood supply to that portion of the
respiratory tract and cause necrosis.
[0104] FIG. 28 depicts one embodiment of the invention, comprising
lung volume displacers 220 that are adapted for positioning in the
apices 222 of the thoracic cavity. When positioned in the thoracic
cavity, the displacers 220 can move the bilateral lungs 224
inferiorly, which in turn will displace the trachea 50 inferiorly.
The lung volume displacers 220 may comprise an inflatable body 226
with an inflation port 228 and an attachment interface. The
attachment interface can configured to engage a catheter, syringe
or both. In one embodiment, the attachment interface comprises a
female Luer adapter, but one skilled in the art will understand
that any of a variety of detachment interfaces may be used. In one
embodiment, the inflation port 228 further comprises a one-way
valve 230 for limiting escape of inflation material from the
inflation body and into the pleural space of the thoracic cavity.
The volume displacers 220 may be filled with any of a variety of
liquids, gaseous fluids or other media, including but not limited
to helium, nitrogen, carbon dioxide, filtered room air, water,
silicone curable foam or polymers or any other biocompatible
materials known in the art. The volume displacers may be placed
through a minimally invasive intercostal insertion site described
below.
[0105] Any of a variety of alternative volume displacement
structures may additionally be utilized in the manner described
above. For example, volume displacing foams, with or without an
outer flexible wall (e.g., a balloon or fabric bag) may be
utilized. Self expandable mechanical structures, such as a Nitinol,
stainless steel or other wire formed into a zig-zag configuration
may be compressed for introduction superior to the lung in the
thoracic cavity, and released to self expand under its own bias and
displace the lung inferiorly.
[0106] For the embodiments discussed herein, the airway
manipulation device, together with the other components of the
present invention can be manufactured in accordance with any of a
variety of techniques which are well known in the art, using any of
a variety of medical-grade construction materials. For example, the
airway manipulation device and other components of the present
invention can be injection-molded, extruded or otherwise formed
from a variety of medical-grade polymers including high or other
density polyethylene, nylon, PEEK, PEBAX and polypropylene.
Portions of the device can be separately formed and secured thereto
in a post-molding operation, using any of a variety of securing
techniques such as solvent bonding, thermal bonding, adhesives,
interference fits, pivotable pin and aperture relationships, and
others known in the art. In certain embodiments, the components of
the tracheal manipulation device may be integrally molded, if the
desired material has appropriate physical properties.
[0107] A variety of absorbable polymers may be useful for the
formation of temporary implants, particularly in the case of
extratracheal implants. Many of these polymers have been reported
to be biodegradable into water-soluble, non-toxic materials which
can be eliminated by the body: Polycaprolactone; Poly (L-lactide),
Poly (DL-lactide); Polyglycolide; Poly (L-Lactide-co-D, L-Lactide)
70:30 Poly (L-Lactide-co-D, L-Lactide); 95:5 Poly
(DL-lactide-co-glycolide); 90:10 Poly (DL-lactide-co-glycolide);
85:15 Poly (DL-lactide-co-glycolide); 75:25 Poly
(DL-lactide-co-glycolide); 50:50 Poly (DL-lactide-co-glycolide);
90:10 Poly (DL-lactide-co-caprolactone); 75:25 Poly
(DL-lactide-co-caprolactone); 50:50 Poly
(DL-lactide-co-caprolactone); Polydioxanone; Polyesteramides;
Copolyoxalates; Polycarbonates and Poly (glutamic-co-leucine).
[0108] The desirability of any one or a blend of these or other
polymers can be determined through routine experimentation by one
of skill in the art, taking into account the mechanical
requirements, preferred manufacturing techniques, and desired
reabsorption time. Optimization can be accomplished through routine
experimentation in view of the disclosure herein.
[0109] The devices can be molded, formed or machined from
biocompatible metals such as Nitinol, stainless steel, titanium,
and others known in the art. Alternatively, the devices may further
comprise a bioresorbable component to promote fibrosis and fixation
of adjacent structures. One suitable bioabsorbable material which
appears to exhibit sufficient structural integrity for the purpose
of the present invention is poly-p-dioxanone, such as that
available from the Ethicon Division of Johnson & Johnson. Poly
(L-lactide, or co-DL-lactide) or blends of the two may
alternatively be used. As used herein, terms such as bioabsorbable,
bioresorbable and biodegradable interchangeably refer to materials
which will dissipate in situ, following a sufficient post-operative
period of time, leaving acceptable byproducts. Bodily reaction to
the bioabsorbable materials or byproducts may furnish at least a
portion of the support provided by the device or treatment
method.
[0110] The device may also comprise a drug eluting component for
treating any inflammation, infection, fibrosis or cellular
proliferation that may result at the implantation site. In one
embodiment of the invention, an endotracheal device with a drug
eluting component may be used to resist the development of tracheal
stenosis.
[0111] In one embodiment of the invention, a method for
manipulating the airway is provided. A patient with
sleep-disordered breathing is identified, at least a portion of the
airway is accessed and the airway is manipulated. In one
embodiment, the airway is manipulated by removal of at least one
tracheal ring along with anastomosis of the two tracheal rings
adjacent to the excised tracheal segment to shorten the
trachea.
[0112] In another embodiment of the invention, a method for
manipulating the airway is provided. The trachea is accessed, the
portion of the tracheal tissue between the cartilaginous rings is
shrunk and the trachea is shortened. The shrinkage of the tissue
may be performed with any of a variety of tissue tightening methods
known in the art, typically by activation of a thermal energy
service such as cryotherapy, ultrasound, laser, microwave and/or
radioablation, or a chemical method such as sclerotherapy.
[0113] In another embodiment of the invention, a method for
manipulating the airway is provided. A patient with
sleep-disordered breathing is identified, the thoracic cavity is
accessed and the airway is manipulated. In one embodiment,
manipulation of the airway is performed by reducing thoracic cavity
volume in its apical regions, to displace the lung parenchyma
inferiorly, thereby manipulating the airway.
[0114] In another embodiment of the invention, a method of
manipulating the airway is provided. A patient with
sleep-disordered breathing is identified, the diaphragm is at least
intermittently activated to increase lung volume and the airway is
displaced inferiorly. In one embodiment of the invention, the
diaphragm is directly stimulated by an electrode to activate the
diaphragm. In another embodiment, the diaphragm is stimulated
indirectly by stimulating the phrenic nerve. In one embodiment,
stimulation is performed with a partially implantable device, such
as an electrode with leads exiting the skin and attaching to an
external power source and controller. In another embodiment,
stimulation is performed by a fully implantable device comprising
an electrode lead connected to a housing with a power source and
controller. The housing can be implanted subcutaneously, similar to
a cardiac pacemaker.
[0115] In other embodiments, the invention further comprises a
sensor for detecting native respiratory activity. Upon detection of
native diaphragm activity, electrical stimulation is provided to
augment the native respiratory activity. In one embodiment, the
phrenic nerve is stimulated by applying electrical current to the
phrenic nerve with electrodes that are positioned over the cervical
vertebrae between C3 and C7. In one embodiment, the electrodes are
placed both posterior and anterior between C3 and C5. In another
embodiment, the diaphragm is directly stimulated by an implantable
electrode.
[0116] In another embodiment, a stimulation device is provided that
comprises a generally flat back plate that is configured to be
placed below a patient's back when the patient is lying down.
Further, at least two electrodes are coupled to the stimulation
device to electrically stimulate the patient. For example, the
electrodes may be employed to electrically stimulate the phrenic
nerve in a manner similar to other embodiments described
herein.
[0117] The electrical current may be provided in multiphasic form.
For example, the wave form may be biphasic, including asymmetrical
biphasic. Depending on the particular treatment, the electrical
signal may be within certain current ranges, certain frequency
ranges, and certain pulse width ranges. In one example, biphasic
electrical current may be used that is in the range from about 100
milliamps to about 2,000 milliamps at a frequency in the range from
about 10 Hz to about 100 Hz, and in pulse widths in the range from
about 1 microsecond to about 5 milliseconds. The stimulator may be
activated from about 10 to about 100 times per minute.
[0118] As shown in FIGS. 29A and 29B, the patient 240 may be
premedicated with atropine to decrease respiratory secretions and
also codeine to provide patient comfort and decrease cough during
the procedure. The patient may also be provided supplemental oxygen
by nasal cannula to keep hemoglobin saturation at least about 90%
during the procedure. Topical lidocaine or a superior laryngeal
nerve block is used to anesthetize the pharynx and vocal cords. The
bronchoscope 242 may be passed through the nostril using lidocaine
jelly for anesthesia and lubrication. Alternatively, the
bronchoscope 242 may be passed orally after insertion of an oral
airway or bite-block. After the nasopharynx and larynx are
inspected, the scope is passed through the vocal cords during
inspiration.
[0119] Upon access to the trachea 50, the device can be implanted
as previously described for the particular embodiment of the
invention. Any of a variety of bronchoscopic tools may be used to
facilitate implantation of the device, including but not limited to
forceps, suturing tools, scissors, staplers and others. Following
tracheal manipulation, the bronchoscope 242 is withdrawn and erect
PA and lateral chest x-rays are obtained to check for
pneumothorax.
[0120] To provide access to the airway, one embodiment of the
invention provides an open surgical approach to the trachea. The
patient undergoes general inhalational anesthesia with endotracheal
intubation for mechanical respiratory support. The patient is
positioned and draped on the operating table in the usual sterile
fashion.
[0121] As depicted in FIGS. 30A through 30C, in one embodiment of
the invention, the cervical portion 250 of the trachea is accessed.
The patient's neck is hyperflexed to enhance exposure to the
surgical site. In some instances, hyperflexion of the neck may also
displace up to about 50% of the trachea above the thoracic outlet.
A horizontal incision 252 is made over the second or third tracheal
ring after the level of the cricoid cartilage 14 has been
identified. The platysma muscle 254 is horizontally divided and the
strap muscles of the neck are separated from the midline. The
cricoid cartilage is identified and the thyroid isthmus may be
divided and sutured to facilitate access to the tracheal rings, if
necessary. With the second through fourth tracheal rings exposed,
implantation of the particular embodiment of the device may
proceed.
[0122] Additional dissection along the airway may be performed as
needed. Referring to FIG. 30C, if access to the lower tracheal
rings is desired, the upper portion of the sternum 250 may be split
to provide expanded access to the upper half of the trachea 50.
Access to the tracheal lumen may be performed by piercing the
membrane between the exposed tracheal rings. If access to the
tracheal lumen is desired, the second and third tracheal rings may
be vertically incised to enlarge access, as depicted in FIG. 30B.
The fourth tracheal ring may be partially incised if necessary.
Smooth thyroid pole retractors are inserted into the tracheal
incision to spread the opening. In one embodiment, upon
implantation of the tracheal manipulation device, the trachea is
checked for adequate vertical mobility to provide swallowing
ability. Closure of the surgical site is performed with simple skin
sutures.
[0123] In embodiments of the invention where access to the lower
trachea, carina and/or mainstem bronchi is desired, a thoracotomy
approach may be used. During intubation, the left side of the lung
may be selectively intubated so that the right lung may be
collapsed to increase surgical access to the trachea. The patient
is positioned in the left lateral decubitis position. The two ends
of the surgical table may be lowered in an inverted V-shape to
further separate the ribs during the surgery. As shown in FIG. 31,
an incision 258 is made obliquely along the right fourth anterior
intercostal space and is extended behind the scapula if posterior
tracheal access is required. The incision 258 is made down to the
subcutaneous fat and then extended until the pleural space is
reached. A rush of air should be heard and a finger is inserted
into the pleural space to check for pleural adhesions before
completing the thoracotomy incision. The lower trachea is exposed
for implantation of the tracheal manipulation device. After
placement of the implant, a chest tube is placed through the
incision to the apex of the lung and connected to a suction device.
The chest tube is secured to the chest wall with sutures and the
thoracotomy incision is closed. The chest tube site is covered with
Xeroform gauze and a chest x-ray is obtained to confirm function of
the chest tube. The patient is withdrawn from general anesthesia
but remains intubated until weaned from respiratory support.
[0124] In embodiments of the invention where access to the lower
trachea, carina and/or mainstem bronchi is desired through a
minimally invasive procedure, video assisted thorascopic surgery
may be performed. The patient undergoes general inhalational
anesthesia with selective endotracheal intubation of the left lung.
The patient is positioned in the left lateral decubitis position
and draped in the usual sterile fashion. A 1.5 cm horizontal
incision down to the subcutaneous fat is made along the
anterolateral surface of the right sixth intercostal space. With a
tonsillar clamp, a tract is created from the incision site
superiorly, posteriorly and immediately above the superior edge of
the 6th rib to avoid injury to the neurovascular bundle. Upon
entering the pleural space, a rush of air should be heard. A finger
is placed through the tract into the pleural space to confirm that
no adhesions are present.
[0125] As depicted in FIG. 32, the primary trocar 260 or
thorascopic port providing visualization of the thoracic cavity is
then inserted through the tract. Secondary ports 262, 264 are
similarly inserted through smaller incisions at the 6th right
posterolateral intercostal space and 4th right intercostal space to
provide additional access for thorascopic tools to implant the
tracheal manipulation device. Such devices include but are not
limited to graspers, dissectors, scissors, needle holders, stapling
devices, clip appliers, suction/irrigation systems, intracorporeal
suturing devices, ultrasonic coagulators as well as instruments for
delivering the particular tracheal device into the thoracic cavity
and attaching the device to the thoracic structures with respect to
the trachea. Such devices typically have diameters from about 3 mm
to about 12 mm. Upon completion of the procedure, the insertion
sites of the secondary ports 262, 264 are sutured and covered with
Xeroform gauze. The primary port 260 is removed and replaced with a
chest tube inserted into the right apical space. The chest tube is
connected to suction and sutured to the chest wall. The chest tube
site is covered with Xeroform gauze and dressed. A chest X-ray is
obtained and general anesthesia is withdrawn.
[0126] In another embodiment of the invention, FIGS. 33A to 33C
illustrate a method for accessing the pleural cavity. The patient
is prepped and draped in the usual sterile fashion. The patient is
positioned in the right lateral decubitis position. See FIG. 33A.
In FIG. 33B, an incision is made obliquely along the left fourth
anterior intercostal space and is extended behind the scapula if
posterior tracheal access is required. The incision is made down to
the subcutaneous fat and then extended until the pleural space is
reached. A rush of air should be heard and a finger is inserted
into the pleural space to check of pleural adhesions. The catheter
or implant delivery system is inserted into pleural space. If
access to the apex of the pleural cavity is desired, as in FIG.
33C, the catheter or delivery system may be inserted by tracking
the tip against the ribcage until the apex is reached, as
visualized on fluoroscopy. In another embodiment, an incision
closer to the apex of the pleural cavity is made to implant the
device, but the risk of inadvertent damage to the subclavian blood
vessels increases.
[0127] While this invention has been particularly shown and
described with references to embodiments thereof, it will be
understood by those skilled in the art that various changes in form
and details may be made therein without departing from the scope of
the invention. For all of the embodiments described above, the
steps of the methods need not be performed sequentially.
* * * * *